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TRANSCRIPT
Slide 1
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Slide 2 Continuing Education Contact Hours
• Participants must complete the entire presentation/seminar to achieve successful completion and receive contact hour credit. Partial credit will not be given.
• All of the presenters are employees of STERIS Corporation and receive no direct compensation other than their normal salaries for participation in this activity.
• STERIS Corporation is an approved provider of continuing nursing education by the California Board of Registered Nursing, provider number CEP 11681 for 1.0 contact hour along with IAHCSMM and CBSPD.
• STERIS Corporation is providing the speakers and contact hours for this activity. However, products referred to or seen during this presentation do not constitute a commercial support by the speakers.
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Slide 3 Learning Objectives
• Review the processing of devices and common
causes of adverse patient reactions
• Describe recent examples of infections and other
complications due to inadequate reprocessing of
devices used for surgical and therapeutic
procedures
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Slide 4
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Slide 5
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Slide 6
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Slide 7
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Slide 8
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Slide 9
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Slide 10
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Slide 11 Infections
• Surgical site: an infection of the incision or organ/space operated on during a surgical procedure
• Other device-associated
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Slide 12 What could we be missing?
Surgical devices• Reported vs non-reported
• Source of infection, often unknown
Non-surgical devices• e.g., flexible endoscopes (GI) and other semi-
critical or non-critical devices
Latent infections• Some infections can take years to develop
• Mycobacteria, prions
Other complications• Toxicity-related events• Tissue damage• Device breakage
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Slide 13
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Slide 14
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Slide 15
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Slide 16 TASS
A toxin problem
‘Toxic Anterior Segment
Syndrome’
• Inflammation
• Cataract surgery
• Inadequate cleaning,
chemical/organic material residuals
(e.g., from water)
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Slide 17 Orthopaedic Implant Sets
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Slide 18
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Slide 19
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Slide 20 Spaulding (1972)
Cleaning is essential• ‘If its not clean it can not be disinfected or sterilized’
Sterilization is the destruction of all microbial forms
Disinfection is something less than sterilization
• Can destroy most-and often all-microorganisms
Microbial resistance (3 groups)• Most vegetative bacteria/fungi, large/medium lipid viruses
• Tubercle bacilli, small non-lipid viruses
• Bacterial spores
Levels of germicidal (disinfection) action (3 groups)• Low level
• Intermediate level
• High level
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Slide 21
Patient Contact
Examples Device Classification
Minimum Inactivation
Level
Intact skin Non-Critical Cleaning and/or Low/Intermedia
te Level Disinfection
Mucous membranes or non-intact skin
Semi-Critical High Level Disinfection
Sterile areas of the body, including blood contact
Critical Sterilization
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Slide 22
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Slide 23
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Slide 24 Retained Tissue in Arthroscopy
• 7 organ/space surgical site infections after
arthroscopic procedures
• Surgeries performed with a rigid arthroscope
and shaver
• Infections caused by P. aeruginosa
Tosh et al, ICHE 32:1179, 2011
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Slide 25 Investigation
62 of 388 environmental cultures cultured P.
aeruginosa
• Sink, water, drains,
• None from the scope or shaver
P. aeruginosa isolated from patients and from the
decontamination sink and suction bottles had
the same genetic (PFGE) profile
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Slide 26 Observations
• Shaver and accessories steam sterilized
• Arthroscope gas plasma sterilized
• Borescope evaluation of shaver cannula
and handpiece
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Slide 27
Retained tissue
Cleaning
concern
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Slide 28
HypothesisBacteria within the residual tissue survived the
sterilization processes
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Slide 29 Manufacturer’s Cleaning
Instructions
Length of enzymatic soak was about 1
minute:
• Manufacturer’s instructions recommended
10-15 min.
Manufacturer’s instructions recommended
brushing
• Lumens only rinsed with running water
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Slide 30 Intervention
• Adopted manufacturer procedures
• Improved work flow
• Increased training and certification of processing staff
• Implemented instrument tracking
• Routine borescope evaluation of suction channel
Post-Script
King et al, Arthroscopy 22:1046, 2006
After reprocessing and ETO sterilization, 13 of 27 (48%) shaver blades had detectable protein and 17 (63%) had detectable nucleic acid
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Slide 31 Continued Focus on Cleaning
• Microbial and toxicity risk
• Improvements in cleaning instructions
• Attention to detail in reprocessing instructions
• Staff competency is essential
• Cleaning endpoint verification
• Visual and another method
http://www.aami.org/reprocessing/Materials/PDF/
2011_Reprocessing_Summit_publication.pdf
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Slide 32
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Slide 33 Cystoscopy and Pseudomonas
Urology clinic
23 P. aeruginosa infections post-cysto• Urinary tract infection and/or bacteremia
5 environmental cultures positive for P. aeruginosa
• 3 endoscopes, rinse bath, cleaning brush
4 available cultures from patients and the environmental cultures had genetically (PFGE) identical profiles
Wendelboe, J. Urol. 180:588-92, 2008
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Slide 34 Reprocessing Area Review
• Scope cleaned right before a case, not
afterwards
• Environmental surfactant disinfectant used
• Distal end only soaked in disinfectant
• Rinse water used for 2 weeks or until
odiferous
• No alcohol final rinse
• No written procedures
Scope reprocesser had no training and no
regular competency assessments
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Slide 35 Interventions
• Disinfection process ‘cleaned up.’
• No further infections, as of the time of publication
• Joint SUNA/AUA white paper on reprocessing flexible cystoscopies, 2009 http://www.suna.org/resources/cystoscopyWhitePaper.pdf
Hypothesis: “Multiple deviations from manufacturer and best practice recommendations” allowed contamination of endoscopes.
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Slide 36
• Approximately 11 million gastrointestinal
endoscopies are performed annually in the
United States
• Contaminated endoscopes have been linked to
more health care-associated infections than any
other medical device
• Several guideline-issuing organizations assert
that the risk of endoscopy-associated infection
(EAI) is only 1 in 1.8 million procedures
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Slide 37 But….
• Audits have documented widespread lapses in infection control involving medical equipment
• Inspections determined that certain endoscopy equipment was not properly reprocessed for up to several years
• Direct observations in a multisite study revealed that endoscopes were virtually never reprocessed in accordance with guidelines
• Implications are unknown because no epidemiologic studies have determined the risk of infections with reprocessing quality
Ofstead et al, AJIC 41: 734-6, 2013
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Slide 38 Paper Conclusion
• Evidence indicates that current risk estimates are inaccurate, outdated, based on flawed methodology, and can have profound effects on patients
• Current low risk estimates are used to justify the lack of reporting, routine monitoring, patient notification, and laboratory testing following a lapse
• There remains a need for epidemiologic studies to accurately estimate the risks of infections and other complications
Ofstead et al, AJIC 41: 734-6, 2013
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Slide 39 Non-infectious Outbreaks
Usually acute onset
• Less than 24 hours after exposure
• But sometimes can be over an extended time (e.g.,
implant rejection)
Causes often related to lapses in best practice
Microbiology work up negative
• Endotoxin may be suspected
Epidemiology work up is similar to infectious cause
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Slide 40 Glutaraldehyde colitis
• 3 cases of colitis several hours post
sigmoidoscopy
• Recently 2% glutaraldehyde replaced 0.2%
• Rigorous rinsing of sigs instituted another
case further investigation
• Glutaraldehyde odor strong in endoscopy
room
• Source: glutaraldehyde in water bottle tubing
Conclusion: tubing not well rinsed
West et al, Gastroenterology 108:1250, 1995
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Slide 41
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Slide 42
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Slide 43
Keratitis
-M. abscessus
-M. chelonae
Surgical Site Infections
-M. abscessus
-M. chelonae
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Slide 44
Procedures n (%)
Colecistectomy 64,6%
Apendicectomy 4,7%
Diagnosis laparoscopy 3,8%
Oophoroplasty 3%
Miomectomy 2%
Arthroscopy 2%
Histerectomy 2%
Surgical Procedure
(n = 1051)
Atypical Mycobacteria Epidemic
(Rio de Janeiro 2006 / 2007)
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Slide 45
Duarte, 2009
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Slide 46 USA: Washer-Disinfector Study
Table 1. Bacterial strains identified from washer-disinfectors
Bacterial Strains Locations
Mycobacterium neoaurium
Mycobacterium chelonae
Mycobacterium gordonae
Mycobacterium gordonae
Mycobacterium gordonae
Mycobacterium gordonae
Mycobacterium avium
Mycobacterium mucogenicum
Mycobacterium mucogenicum
Mycobacterium mucogenicum
Mycobacterium mucogenicum
Mycobacterium abscessus/chelonae
Mycobacterium abscessus/chelonae
Mycobacterium abscessus/chelonae
Mycobacterium abscessus/chelonae
Methylobacterium fujisawaense
Methylobacterium rhodesianum
Methylobacterium radiotolerans
Methylobacterium extorquens
Bacillus megaterium
Paenibacillus alginolyticus
Water Port
Final Rinse
Cold Tap Spigot
Hot Tap Spigot
Post-Clean Rinse
Rinse 2
Rinse 2
Post Wash-Rinse Suction Line
Fluid Sample-Tap Water
Detergent/Prewash
Rinse 3
Post Wash-Rinse Suction Line
Detergent/Prewash
Rinse 2
Rinse 3
Final Rinse
Feed Water Hose
Hot Tap Spigot
Glutaraldehyde Line
Feed Water Hose
Lid
Fisher et al (2012) AJIC
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Slide 47
0
1
2
3
4
5
6
7
8
Po
pu
lati
on
(L
og
10
)
0 10 15 20
Exposure time (mins)
2.5% Glutaraldehyde
M. gordonae (control)
B. megaterium
M. gordonae
M. avium
P. alginolyticus
M. abscessus/chelonae
M. mucogenicum
M.abscessus/chelonae
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Slide 48
0
1
2
3
4
5
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8
Po
pu
lati
on
(L
og
10
)
0 5 10 15
Exposure time (mins)
0.55% OPAM. gordonae (control)
B. megaterium
M. gordonae
M. avium
P. alginolyticus
M. abscessus/chelonae
M. mucogenicum
M.abscessus/chelonae
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Slide 49
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Slide 50
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Slide 51 Endophthalmitis and Orthopedic
Infections
15 orthopedic and 5 ophthamology cases
• Serious infections
Variety of bacteria: coagulase negative staphylococci,
Bacillus sp, E.faecalis, coliforms
SJ Dancer et al, J Hosp Infect 81:231-238, 2012
Where would you start the investigation?
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Slide 52 After investigation dead-ends, focused
on sterile pack storage
Reports of broken and missing items
10 Surgical packs were damp or
discolored and taken out of
service
10 dry packs were chosen at random
• 20 cultured; 11 grew coagulase
negative staphylococci and/or
Bacillus sp
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Slide 53 Sterile Processing Review
• Not well maintained
• No gowns, gloves or masks in clean area
• Staff in street clothes
• No hand washing sinks in clean area
• Autoclave drainage inadequate
• Insufficient dry time or cooling time for packs
• Carts were corroded
• No covers on sterile packs
Overall insufficient drying and maintenance of sterile packs
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Slide 54 Compromised Sterile Packaging
(damp packs or rapid cooling)
Intervention and recommendations included
• Tightening of practices in sterile processing
• Adequate cooling and drying
• Weekly audit, internal
• Routine visits, external, IPs
• Upgrade staff attire
• Increase environmental cleaning
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Slide 55 Conclusions
• Reusable medical devices, including surgical
devices, require strict attention to
reprocessing instructions
• The full reprocessing cycle should be
consider, each step being important
• Infections and other complications have
occurred due to inadequate reprocessing of
devices
• These are under-reported
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Slide 56 Evaluation and Registration
• Thank you for attending this CE activity
• Please complete and submit the evaluation form
• For more information on the CE credentialed programs offered, go to http://university.steris.com
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Slide 57
Industry Journals covered launch : July 19, 2011:
“The largest catalogue to date of STERIS’s highly flexible adult learning opportunities, including
webinars, seminars, online instruction, published papers and self-study articles, all in one easily
accessed location. Education comes to learners at their convenience.”
“STERIS Launches New Healthcare Education Portal”
“STERIS University promises to be a ‘Knowledge factory’ for healthcare professionals”
STERIS University Customer Website
Customer site launched July 18, 2011
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Slide 58
Go to: http://university.steris.com
STERIS University
Playing a part in your professional development today to help you achieve your career vision for tomorrow
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Slide 59 References
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